A Real-World Assessment of Stage I Lung Cancer Through Electronic Nose Technology.
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Rocco Gaetano, Pennazza Giorgio, Tan Kay See, Vanstraelen Stijn, Santonico Marco, Corba Robert J, Park Bernard J, Sihag Smita, Bott Matthew J, Crucitti Pierfilippo, Isbell James M, Ginsberg Michelle S, Weiss Hallie, Incalzi Raffaele Antonelli, Finamore Panaiotis, Longo Filippo, Zompanti Alessandro, Grasso Simone, Solomon Stephen B, Vincent Alain, McKnight Alexa, Cirelli Michael, Voli Carmela, Kelly Susan, Merone Mario, Molena Daniela, Gray Katherine, Huang James, Rusch Valerie W, Bains Manjit S, Downey Robert J, Adusumilli Prasad S, Jones David R
Аннотация
METHODS: This phase IIc trial (NCT04734145) included patients diagnosed with a single greater than or equal to 50% solid stage I nodule. Exhalates were prospectively collected from January 2020 to August 2023. Blinded bioengineers analyzed the exhalates, using E-nose technology to determine the probability of malignancy. Patients were stratified into three risk groups (low-risk, [<0.2]; moderate-risk, [≥0.2-0.7]; high-risk, [≥0.7]). The primary outcome was the diagnostic performance of E-nose versus histopathology (accuracy and F1 score). The secondary outcome was the clinical performance of the E-nose versus clinicoradiological prediction models.
RESULTS: Based on the predefined cutoff (<0.20), E-nose agreed with histopathologic results in 86% of cases, achieving an F1 score of 92.5%, based on 86 true positives, two false negatives, and 12 false positives (n = 100). E-nose would refer fewer patients with malignant nodules to observation (low-risk: 2 versus 9 and 11, respectively; p = 0.028 and p = 0.011) than would the Swensen and Brock models and more patients with malignant nodules to treatment without biopsy (high-risk: 27 versus 19 and 6, respectively; p = 0.057 and p < 0.001).
CONCLUSIONS: In the setting of clinical stage I lung cancer, E-nose agrees well with histopathology. Accordingly, E-nose technology can be used in addition to imaging or as part of a "multiomics" platform.